MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C1450
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400's (pc400's).During the procedure, the physician noticed after deploying the first pc400 using a px slim delivery microcatheter (px slim) that the size of the coil did not fit in the target vessel.He retracted the first pc400 and deployed the second pc400 but after 10 cm of the coil was deployed from the px slim the physician experienced resistance and retracted the coil out of the patient¿s body.It was noticed that 3 cm of the sr wire was exposed from the proximal end of the coil and the tip of coil was distorted.The procedure was completed using additional nine pc400 and three non-penumbra coils with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The embolization coil had offset coil winds.Coagulated blood was present inside the introducer sheath.The coil winds were compressed on the proximal end of the embolization coil exposing approximately 3.0 cm of sr wire.The coil 400 was attempted to be advanced out of its introducer sheath and was unable to be advanced or retracted through its introducer sheath.Conclusion: evaluation of the returned pc400 revealed a device with offset coil winds.The reported complaint mentioned that resistance was experienced after the coil was advanced 10 cm out of the px slim microcatheter.If the pc400 is forcefully advanced while experiencing resistance, damage such as offset coil winds may occur.If the device is retracted while experiencing resistance or has offset coil winds, the sr wire may become exposed.The px slim was not returned for evaluation; therefore, the root cause of the initial resistance was unable to be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8030379
• Report Number: 3005168196-2018-02160
• Device Sequence Number: 1578574
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2026
• Device Catalogue Number: 4002C1450
• Device Lot Number: F81331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005